A long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.

A long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.

Int J Neuropsychopharmacol. 2018 Feb 03;:

Authors: Forbes A, Hobart M, Ouyang J, Shi L, Pfister S, Hakala M

Abstract
Background: Brexpiprazole is a serotonin-dopamine activity modulator with efficacy in acute schizophrenia and relapse prevention. The aim of this Phase 3, multicenter study was to assess the long-term safety, tolerability, and efficacy of treatment with brexpiprazole flexible-dose 1-4 mg/day.
Methods: Patients rolled over into this 52-week open-label study (amended to 26 weeks towards the end) from three randomized, double-blind, placebo-controlled Phase 3 studies. De novo patients, not part of the previous studies, were also enrolled. The primary outcome variable was the frequency and severity of treatment-emergent adverse events (TEAEs). Efficacy was assessed as a secondary objective using the Positive and Negative Syndrome Scale and the Personal and Social Performance scale.
Results: A total of 1,072 patients were enrolled (952 for 52 weeks and 120 for 26 weeks), 47.4% of whom completed the study. Among patients who took at least one dose of brexpiprazole, 14.6% discontinued due to TEAEs, most commonly schizophrenia (8.8%) and psychotic disorder (1.5%). TEAEs with an incidence of ≥5% were schizophrenia (11.6%), insomnia (8.6%), weight increased (7.8%), headache (6.4%), and agitation (5.4%). Most TEAEs were mild or moderate in severity. The mean increase in body weight from baseline to Week 26 was 1.3 kg, and to Week 52 was 2.1 kg. There were no clinically relevant findings related to prolactin, lipids and glucose, or QT prolongation. On average, patients' symptoms and functioning showed continual improvement.
Conclusions: Treatment with brexpiprazole 1-4 mg/day was generally well tolerated for up to 52 weeks in patients with schizophrenia.
ClinicalTrials.gov identifier: NCT01397786 (https://clinicaltrials.gov/show/NCT01397786).